Recall Z-2216-2008 ยท LXH Orthopedic Manual Surgical Instrument
Wright Medical Technology Inc
Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the preparation of the implant site prior to device implantation.
| Date | Sep 17, 2008 (initiated May 20, 2008) |
| Status | Terminated |
| Reason | Trials are 2.5mm larger than marked. |
| Root cause | Component change control |
| Action | The firm initiated their recall on May 20, 2008 by issuing a Field Notice to their distributors and followed with telephone calls on May 21 and 22, 2008 requesting the return of the products. The firm then issued letters to their distributors on June 4, 2008 explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals were notified of the recall also on June 4, 2008 by means of letters, delivered via Fed Ex, addressed to Hospital Administrators, Ri |
| Quantity | 127 units |
| Distribution | Worldwide Distribution --- including USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.